BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3056072 · Received April 12, 2013

    Report

    Report Number
    1030489-2013-01018
    Event Type
    Injury
    Date Received
    April 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN OFFICE VISIT. PER THE PHYSICIAN'S NOTES, PATIENT HAS "A 20 YEAR HISTORY OF LOW BACK AND BILATERAL-LOWER EXTREMITY PAIN" THE PAIN RADIATES DOWN THE POSTEROLATERAL ASPECT OF HIS BILATERAL THIGHS AND THE LATERAL ASPECT OF HIS BILATERAL LOWER LEGS. HE REPORTS PARESTHESIAS IN A SIMILAR DISTRIBUTION. HE REPORTS THAT HIS RIGHT LEG PAIN IS ONLY GREATER DUE TO THE FACT THAT HE HAS FRACTURED IT AND HAS HAD OPEN REDUCTION INTERNAL FIXATION FOR IT. HE ALSO HAS BILATERAL TOTAL HIP REPLACEMENTS. PATIENT HAS HAD THREE LUMBAR SPINE SURGERIES IN THE 1990'S, INCLUDING TWO DECOMPRESSIONS AND ONE FUSION WHICH, BY IMAGING, APPEARS TO BE ATL5-S1. X-RAYS OF THE LUMBAR SPINE INDICATED "PARTIAL DECOMPRESSIONS AT L4-5 AND L5-S1. THERE DOES APPEAR TO BE BONY FUSION AT L5-S1. THERE IS NO EVIDENCE OF NEW INSTABILITY, FRACTURE OR DISLOCATION". THE PATIENT UNDERWENT AN L4-5 TLIF, L5-S1 DECOMPRESSION TO TREAT L4-S1 STENOSIS AND LUMBAR RADICULITIS. LOCAL BONE, BMP, AND ACCEL SPINE CAGE WERE USED. THERE WERE NO NOTED COMPLICATIONS. PATIENT DISCHARGED ON POD 2. SIXTEEN DAYS POST-OP, THE PATIENT PRESENTED FOR OFFICE VISIT. PER PHYSICIAN'S NOTES, "PATIENT REPORTS HE IS STILL HAVING LATERAL BILATERAL LOWER EXTREMITY LEG PAIN THAT HE HAD PRIOR TO SURGERY HOWEVER HE DOES HAVE NEW RIGHT THIGH NUMBNESS. HE STATES HE IS STILL HAVING SIGNIFICANT BACK PAIN AS WELL. HE IS TAKING 8 PERCOCET PER DAY". THIRTY-EIGHT DAYS POST-OP, THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "THE PATIENT REPORTS PAIN AND NUMBNESS IN THE RIGHT ANTEROLATERAL THIGH". AND, "RIGHT ANTEROLATERAL THIGH NUMBNESS WHICH IS LIKELY NEURALGIA PARESTHETICA FROM POSITION ON THE OPERATIVE TABLE". CT SCAN INDICATED "THE INTERBODY CAGE, SCREWS AND RODS TO BE IN GOOD POSITION AND ALIGNMENT". MRI SCAN INDICATED "L4-5: THERE APPEARS TO BE POSTERIOR DISC PROTRUSION 2.6 MM, CENTRAL IN LOCATION. NO CENTRAL STENOSIS. THERE APPEARS TO BE BILATERAL NEURAL FORAMINA STENOSIS DUE TO FACET JOINT HYPERTROPHY, AND POSTERIOR MARGINAL BONE SPURS, LEFT GREATER THAN RIGHT. L5-S1: THERE IS RIGHT PARACENTRAL POSTERIOR DISC OSTEOPHYTE COMPLEX WITH DISC PROTRUSION, RESULTING IN IMPINGEMENT UPON THE DESCENDING RIGHT S1 NERVE ROOT. THERE IS ALSO RIGHT NEURAL FORAMINAL STENOSIS". AND "NO SIGNIFICANT CENTRAL CANAL OR NEUROFORAMINAL STENOSIS. THERE IS POSTOPERATIVE FLUID COLLECTION WHICH IS ROUTINELY SEEN". SIXTY-FIVE DAYS POST-OP, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DEPRESSION AND CHRONIC BACK PAIN. THE PATIENT WAS ADMITTED TO INPATIENT PSYCHIATRIC UNIT FOR STABILIZATION. PER THE MEDICAL RECORD, THE PATIENT HAD "INTERMITTENT COMMAND AUDITORY HALLUCINATIONS OF VOICES TELLING HIM THAT HE IS WORTHLESS AND HE NEEDS TO BE IN HEAVEN WITH HIS FATHER AND OTHER FAMILY MEMBERS. THE PATIENT IS ALSO STRESSED BECAUSE OF HIS COURT HEARING FOR HIS DUI CHARGES AND HE IS AT POSSIBLY WILL BE GOING TO PRISON FOR FEW YEARS". THE PATIENT WAS DIAGNOSED WITH MAJOR DEPRESSIVE DISORDER, RECURRENT SEVERE WITH PSYCHOSIS, ALCOHOL DEPENDENCE IN REMISSION, AND CHRONIC PAIN. PATIENT WAS DISCHARGED AFTER 15 DAYS. ONE HUNDRED THIRTY-SIX DAYS POST-OP THE PATIENT PRESENTED FOR FOLLOW UP. PER THE PHYSICIAN'S NOTES, "THE PATIENT REPORTS THAT HE CONTINUES TO HAVE BACK PAIN AS WELL AS RIGHT THIGH NUMBNESS". X-RAYS INDICATED "THE INTERBODY SPACER AND POSTERIOR SCREWS AND ROD TO BE IN GOOD POSITION AND ALIGNMENT WITHOUT EVIDENCE OF GRAFT SUBSISTENCE OR HARDWARE FAILURE OR SCREW PULLOUT". THE PATIENT'S ATTORNEY ALLEGES AN EXACERBATION OF PATIENT'S DEPRESSION DUE TO CHRONIC PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6)-2011: THE PATIENT UNDERWENT SPINAL FUSION SURGERY USING RHBMP-2/ACS. (B)(6)-2011: THE PATIENT PRESENTED WITH BONE GROWTH TUMORS. AT L4-5: SCLEROTIC CHANGES IN ENDPLATES WERE OBSERVED, SEVERE NARROWING CENTRAL CANAL SECONDARY TO OSSEOUS OR METALLIC STRUCTURES SEEN AT LEVEL OF SURGICAL BED. ALSO THE PATIENT PRESENTED WITH NERVE DAMAGE. TYPE: RADICULOPATHY, NEUROPATHIC PAIN. (B)(6)-2011: THE PATIENT WAS HOSPITALIZED FOR 1 DAY DUE TO CHRONIC BACK PAIN AND DEPRESSION. (B)(6)-2012: THE PATIENT PRESENTED WITH CHRONIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158820 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention